Amgen Oncology Highlights Upcoming Data Presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting.Clinical Data to be Presented on Seven Investigational Targeted and Supportive Care supportive care, n medical and other interventions that attempt to support and make comfortable rather than to cure. Cancer Therapies from Oncology Pipeline THOUSAND OAKS, Calif. -- Amgen (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :AMGN), today announced upcoming data presentations of interest at the 43rd Annual American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) Meeting in Chicago. Clinical data will be presented on seven investigational therapies: AMG AMG All Music Guide (music website) AMG All Media Guide (group of media websites) AMG All Movie Guide (Movie website) AMG Arzneimittelgesetz (German Law) 531 in thrombocytopenic thrombocytopenic of the nature of or pertaining to thrombocytopenia. patients with myelodysplastic syndrome Myelodysplastic Syndrome Definition Myelodysplastic syndrome (MDS) is a disease that is associated with decreased production of blood cells. Blood cells are produced in the bone marrow, and the blood cells of people with MDS do not mature normally. (MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there ), motesanib diphosphate di·phos·phate n. An ester of phosphoric acid containing two phosphate groups. (AMG 706) in locally advanced or metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. thyroid cancer Thyroid Cancer Definition Thyroid cancer is a disease in which the cells of the thyroid gland become abnormal, grow uncontrollably, and form a mass of cells called a tumor. ; and AMG 102, AMG 386, AMG 479, AMG 655, and rhApo2L/TRAIL in patients with advanced solid tumors. This is the first time that Phase 1 clinical data for AMG 102, AMG 386, AMG 479 and AMG 655 will be presented. In addition, updated data from the Vectibix[TM] (panitumumab) 250 (EGFR EGFR Epidermal Growth Factor Receptor (a kinase enzyme) EGFR Estimated Glomerular Filtration Rate low/negative) study, and health-related quality of life (QOL QOL, n quality of life, a subjective assessment of one's emotional and physical well-being. ) and patient reported outcome (PRO) data from the pivotal 408 trial, will be presented. "As the science of cancer rapidly evolves, Amgen is developing the next generation of targeted therapeutics and novel supportive care agents," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "The data we are presenting at ASCO this year reflect the breadth and diversity of our oncology research pipeline." The following are selected studies of interest being presented on Amgen's marketed products and investigational compounds this year at ASCO: Marketed Products Aranesp(R) (darbepoetin alfa) -- Effects of intravenous iron supplementation on responses to every-3-week darbepoetin alfa by baseline hemoglobin in patients with chemotherapy-induced anemia Abstract No. 9106 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S Hall A2, General Poster Session) -- Baseline predictors of response to treatment with darbepoetin-alpha in anemic patients with low-risk myelodysplastic syndrome Abstract No. 7081 (Saturday, June 2, 8:00 a.m. - 12:00 p.m., S Hall A2, General Poster Session) -- Second interim analysis of the ARA Plus study: Breast Cancer adjuvant chemotherapy with and without darbepoetin-alpha, analysis of serious adverse events. (This is an independent investigator-led study that is part of the Aranesp Pharmacovigilance program) Abstract No. 564 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S Hall A2, General Poster Session) Vectibix(TM) (panitumumab) -- Panitumumab activity in metastatic colorectal cancer patients with low or negative tumor epidermal growth factor receptor levels: An Updated analysis Abstract No. 4082 (Monday, June 4 8:00 a.m. - 12:00 p.m., S Hall A2, General Poster Session) -- Patient-reported outcome-assessed clinical benefit of panitumumab in metastatic colorectal cancer patients Abstract No. 6560 (Saturday, June 2, 8:00 a.m. - 12:00 p.m., S Hall A2, General Poster Session) -- Association of skin toxicity severity with clinical outcomes and health-related quality of life with panitumumab Abstract No. 4038 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S403, Poster Discussion Session) Investigational Compounds AMG 531 -- Evaluating safety and efficacy of AMG 531 for the treatment of thrombocytopenic patients with myelodysplastic syndrome: preliminary results of a Phase 1/2 study Abstract No. 7032 (Monday, June 4, 8:00 a.m. - 12:00 p.m., E451a, Poster Discussion Session) Motesanib Diphosphate (AMG 706) -- Initial results from a Phase II trial of motesanib diphosphate (AMG 706) in patients with differentiated thyroid cancer Abstract No. 6017 (Monday, June 4, 8:00 a.m. - 12:00 p.m., S Hall A2, Poster Discussion Session) AMG 102 -- Interim results from a first-in-human study of AMG 102, a fully human monoclonal antibody that neutralizes hepatocyte growth factor, the ligand to c-Met receptor, in patients with advanced solid tumors Abstract No. 3551 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S102a, Poster Discussion Session) AMG 386 -- First-in-human study of AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in adult patients with advanced solid tumors Abstract No. 3522 (Saturday, June 2, 7:45 a.m. - 8:00 a.m., E354b, Oral Presentation) AMG 479 -- A Phase 1 pharmacokinetic and pharmacodynamic study of AMG 479, a fully human monoclonal antibody against insulin-like growth type 1 receptor, in advanced solid tumors Abstract No. 3002 (Monday, June 4, 7:45 a.m. - 8:00 a.m., S100a, Clinical Science Symposium) AMG 655 -- First-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumors Abstract No. 3534 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S102a, Poster Discussion Session) rhApo2L/TRAIL (a) -- Application of pharmacodynamic assays in a Phase 1a trial of Apo2L/TRAIL in patients with advanced tumors Abstract No. 3535 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S102a, Poster Discussion Session) -- A Phase 1b safety and pharmacokinetic study of recombinant human Apo2L/TRAIL in combination with rituximab in patients with low grade non-Hodgkin's lymphoma Abstract No. 8078 (Saturday, June 2, 8:00 a.m. - 12:00 p.m., S Hall A2, General Poster Session) (a)This compound is being developed in collaboration with Genentech, Inc. Webcast Information Amgen will host a webcast with the investment community on Monday, June 4, at 9 p.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT to discuss data presented at ASCO. Open to members of the news media, investors and the general public, the webcast can be found on Amgen's Web site, www.amgen.com, under Investors. It will be archived and available for replay for at least 72 hours after the event. About Aranesp Aranesp was approved by the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in September 2001 for the treatment of anemia associated with chronic renal failure chronic renal failure Chronic kidney failure Nephrology A slow decline in renal function, which may be 2º to chronic HTN, DM, CHF, SLE, or sickle cell anemia and, if extreme, leads to ESRD, mandating kidney dialysis; an abrupt decline in renal function may be (CRF CRF abbr. chronic renal failure CRF Chronic renal failure ), for patients on dialysis and patients not on dialysis. In July 2002, the FDA approved weekly dosing of Aranesp for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy, and in March 2006, the FDA approved every-three-week dosing in these patients. Important Safety Information including boxed WARNING Use the lowest dose of Aranesp that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell red blood cell: see blood. transfusion. Aranesp and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL Cancer Patients: Use of ESAs * Shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL, * Shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin of greater than 12 g/dL, * Increased the risk of death when administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy or radiation therapy. ESAs are not indicated for this population. Patients receiving ESAs pre-operatively for reduction of allogeneic allogeneic /al·lo·ge·ne·ic/ (-je-ne´ik) 1. having cell types that are antigenically distinct. 2. in transplantation biology, denoting individuals (or tissues) that are of the same species but antigenically red blood cell transfusions: A higher incidence of deep venous thrombosis deep venous thrombosis n. Abbr. DVT A condition in which one or more thrombi form in a deep vein, especially in the leg or pelvis, resulting in an increased risk of pulmonary embolism. was documented in patients receiving Epoetin alfa e·po·e·tin al·fa n. A recombinant preparation of human erythropoietin used to treat some forms of anemia. epoetin alfa Epogen, Eprex (CA) (UK), Procrit Pharmacologic class: who were not receiving prophylactic anticoagulation. Aranesp is not approved for this indication. Aranesp is contraindicated in patients with uncontrolled hypertension. The Aranesp prescribing information, including important safety information and boxed warning, may be accessed at www.aranesp.com. About Vectibix Vectibix is indicated for the treatment of EGFr-expressing, metastatic colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. The effectiveness of Vectibix for the treatment of EGFr-expressing, metastatic colorectal cancer is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. Important Product Safety Information Dermatologic toxicities, related to Vectibix blockade of EGF EGF abbr. epidermal growth factor binding and subsequent inhibition of EGFr-mediated signaling pathways, were reported in 89 percent of patients and were severe (NCI-CTC grade 3 and higher) in 12 percent of patients receiving Vectibix monotherapy. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus pruritus /pru·ri·tus/ (proo-ri´tus) itching.prurit´ic pruritus a´ni intense chronic itching in the anal region. pruritus hiema´lis xerotic eczema. , erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns. , rash, skin exfoliation exfoliation /ex·fo·li·a·tion/ (eks-fo?le-a´shun) 1. a falling off in scales or layers. 2. the removal of scales or flakes from the surface of the skin. 3. , paronychia paronychia /par·onych·ia/ (par?-ah-nik´e-ah) inflammation involving the folds of tissue around the fingernail. par·o·nych·i·a n. Inflammation of the tissue surrounding a nail. , dry skin, and skin fissures. Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities. Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients. Severe infusion reactions were identified by reports of anaphylactic anaphylactic /ana·phy·lac·tic/ (an?ah-fi-lak´tik) pertaining to anaphylaxis. anaphylactic (an´ reaction, bronchospasm bronchospasm /bron·cho·spasm/ (brong´ko-spazm) bronchial spasm; spasmodic contraction of the smooth muscle of the bronchi, as in asthma. bron·cho·spasm n. , fever, chills, and hypotension hypotension or low blood pressure Condition in which blood pressure is abnormally low. It may result from reduced blood volume (e.g., from heavy bleeding or plasma loss after severe burns) or increased blood-vessel capacity (e.g., in syncope). . Although fatal infusion reactions have not been reported with Vectibix, fatalities have occurred with other monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing Vectibix, depending on the severity and/or persistence of the reaction. About Amgen Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease Kidney Disease Definition Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. , rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com. Forward-Looking Statements This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and most recent periodic reports on Form 10-Q Form 10-Q See 10-Q. and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of May 29, 2007 and expressly disclaims any duty to update information contained in this news release. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the FDA, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release. |
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